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- Duane Morris’ Michael Swit to Present on "Navigating the Regulatory Landscape"
- Duane Morris Special Counsel Michael Swit to Present an "Update on FDA Development for Biosimilars"
- Duane Morris Attorneys Matthew Jones and Melissa Sobel Snyder To Speak at Pennsylvania Bar Institute's Understanding the Basics of Health Law
- FDA Seeks Information for Implementation of Drug Supply Chain Security Act
- FDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees
- FDA's New Interpretation of the Five-Year NCE Exclusivity Provisions of Federal Food, Drug, and Cosmetic Act
Pharmaceutical, Medical Device, Pharmacy & Food
The pharmaceutical, medical device, pharmacy and food industries have far-reaching scope and are integral to our daily lives. Duane Morris attorneys counsel clients in these industries on virtually all aspects of their business and at all stages of the client's lifecycle, from bringing new products to market and responding to agency enforcement actions to integrating Good Manufacturing Practices, as well as corporate compliance, due diligence and products liability matters.
Our services range from review of promotional materials, price reporting, adverse event reporting, import and export issues, and manufacturing questions. We review self-evaluative audits, design corrective action plans and, when warranted, assist in reporting possible violations to regulatory authorities. As a full-service law firm, we use a multidisciplinary approach to advise clients on compliance with the complex legal issues that involve different legal areas, such as the Foreign Corrupt Practices Act, criminal defense, antitrust laws, products liability matters and intellectual property. Our efforts are focused on managing risk and navigating a complex regulatory environment while achieving our clients' business goals.
We regularly assist clients in dealing with governmental regulatory agencies, including the FDA, Drug Enforcement Administration (DEA), Centers for Medicare and Medicaid Services, Office of Inspector General, Department of Health and Human Services, the U.S. Department of Justice, the FDA Office of Criminal Investigations, and state regulatory authorities. Our experience includes representing clients in regulatory enforcement actions, False Claims Act litigation, internal investigations, fraud and abuse, off-label promotion and alleged violations of the Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act and federal and state anti-kickback statutes. To help prevent costly litigation and enforcement actions, we focus on preventative counseling and help clients develop and implement corporate compliance plans.
Pharmaceutical and Medical Device
From major multinational corporations seeking to expand market share to startups with ideas growing in the laboratory, life sciences companies of all levels of maturity turn to Duane Morris for counsel and representation aimed at improving their organizational health. Our attorneys are experienced in navigating the challenges posed by the development, manufacture, marketing and sales of medical devices, biologics and pharmaceuticals, including a significant focus on generic drugs. We seek to quickly and effectively clear regulatory hurdles while protecting our clients' intellectual property and monetary assets.
A significant portion of our practice centers on counseling clients on compliance with the FDA's statutory and regulatory requirements, drug and device approvals, dietary supplement health claims, regulatory issues in corporate acquisitions, recalls and crisis management. Additionally, we advise clients on critical partnering, licensing and financing transactions, as well as significant operational agreements for manufacturing and supply, distribution, and pre-clinical and clinical research. We also help clients understand the complexities of price reporting to federal agencies and have represented drug clients in litigation involving claims related to price reporting.
Duane Morris lawyers also advise clients on how to bring generic drugs to market under the Hatch-Waxman Amendments to the federal Food, Drug, and Cosmetic Act. We counsel on drug approvals and market entry strategies—including Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs, and ANDA suitability petitions—working through answers to questions related to eligibility for the abbreviated and 505(b)(2) application processes, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions.
In the device arena, we help device and diagnostic companies develop and execute the regulatory strategies to bring their products to the market and keep them there, including counseling on device classifications and the appropriate approval route at FDA, whether under the PMA or 510(k) processes. We also have worked on reclassification petitions and other steps to ensure that our clients secure the protection of the statute's commitment to the least burdensome approach to the regulation of safe and effective devices. In so doing, we also incorporate guidance on satisfying the reimbursement requirement of governmental payers such as Medicare/Medicaid and the private insurers.
We also advise clients on the appropriate child-resistant packaging that many drugs must be packaged in pursuant to the Child Safety Protection Act (CSPA), which is enforced by the Consumer Product Safety Commission (CPSC).
Working at the crossroads of science and business, many Duane Morris lawyers call upon their knowledge gained through previous positions as toxicologists, chemists, pharmacists and laboratory researchers, as well as their advanced degrees in biology, biochemistry and molecular and developmental genetics, when assessing clients' specialized legal needs. As many of our attorneys have direct industry experience as executives and in-house counsel for pharmaceutical and biotechnology companies, we understand the issues clients face from the clients' perspective. We are able to provide teams of lawyers who practice in diverse legal disciplines—such as patents and intellectual property, corporate finance and securities law, international trade and taxation, labor and employment law, products liability and other litigation—all of whom have experience handling matters for pharmaceutical and biotechnology clients.
All of the firm's patent lawyers and patent agents have science or engineering backgrounds, many with advanced degrees, and most have significant industry experience in their respective disciplines, including:
- Advanced materials
- Medical and mechanical devices
- Abbreviated New Drug Application and related litigation
- Medicinal chemistry
- Small molecule chemistry
- Combinatorial chemistry
- Organic chemistry/synthetic pathways
When our attorneys enter a courtroom, they are adept at explaining complex technical issues in a straightforward manner and presenting our client's story to the judge and jurors in the most compelling way possible. We handle patent litigation for large and small corporations as well as individual inventors and startup enterprises. We also are experienced in conducting interference proceedings before the U.S. Patent and Trademark Office.
Our clients include generic and specialty pharmaceutical manufacturers, manufacturers of biologics, and device and diagnostic manufacturers.
Our lawyers regularly represent the pharmacy industry in a variety of matters, such as reimbursement litigation, third-party payor audits (including state audits), allegations of diversion, the complex legal landscape of federal and state anti-kickback statutes and issues before state boards of pharmacy. We have a deep understanding of the legal framework governing compounding.
Duane Morris attorneys assist clients in dealing with state boards of pharmacy, the Office of Inspector General, state boards of health and human services, the DEA and other regulatory agencies.
We have represented the industry in major litigation involving the calculation of average manufacturer price, the calculation of federal upper limits and other reimbursement litigation.
Our clients include national and numerous state pharmacy associations. We represent major chains as well as the community pharmacist. Because of our broad client base, we understand the business of pharmacy.
Our lawyers assist food and dietary supplement industry clients with the legal, regulatory, competitive and other business challenges they face. Duane Morris advises on regulatory compliance, enforcement risk and corrective action; draft notifications, petitions and other voluntary or mandatory submissions; and complaints against competitors. Our goal is to advance and defend our clients' interests before courts as well as federal and state enforcement officials and in the marketplace.
Compliance and Enforcement
For our pharmaceutical, medical device, food and pharmacy clients, we advise them regarding compliance with myriad statutory and regulatory requirements, guidance documents and informal policies, including those governing:
- Labeling and advertising claims, including triggered disclaimers
- FDA inspections, including responding to Form FDA 483 inspectional observations and warning letters
- Recalls and market withdrawals
- Corrective actions
- Import detentions
- Seizures, injunctions and criminal prosecutions
- Complaints by or about competitors
- Mandatory and voluntary submissions
We have represented these clients in enforcement actions initiated by the Department of Justice, FDA and the Federal Trade Commission, and before the National Advertising Division of the Better Business Bureau. We also help clients with issues involving Good Manufacturing Practices, labeling and overseas sourcing.
In addition, we provide training to clients on ensuring compliance in all areas impacting their operations.